Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial
Not Applicable
- Conditions
- Percutaneous Coronary Intervention
- Registration Number
- NCT02269449
- Lead Sponsor
- NPO International TRI Network
- Brief Summary
The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1900
Inclusion Criteria
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
- Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patient who can accept radial access.
Exclusion Criteria
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Hemodialysis patient
- STEMI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Radial artery occlusion Day 1 Local bleeding from puncture site Day 1
- Secondary Outcome Measures
Name Time Method Vascular access site complication Day 1 Procedure success rate Day 1 Radial spasm during the index procedure Day 1 Total Procedure Time Day 1 Pain score Day 1 Total Radiation Doses Day 1 Device failure for the assigned sheath introducer Day 1 Total Amount of Contrast Dye Day 1